UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062923 |
|---|---|
| Receipt number | R000072040 |
| Scientific Title | Efficacy Evaluation study of a test food for maintaining cognitive function -Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study- |
| Date of disclosure of the study information | 2026/10/09 |
| Last modified on | 2026/09/14 18:07:43 |
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Basic information
Public title
Efficacy Evaluation study of a test food for maintaining cognitive function
Acronym
Efficacy Evaluation study of a test food for maintaining cognitive function
Scientific Title
Efficacy Evaluation study of a test food for maintaining cognitive function
-Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study-
Scientific Title:Acronym
Efficacy Evaluation study of a test food for maintaining cognitive function
-Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study-
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of 24-week continuous intake of the test food on maintaining cognitive function in Japanese men and women aged 55 to under 80 years.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-MoCA-J
-Cognitrax Basic
Key secondary outcomes
-Plasma beta-amyloid 1-42 concentration
-Plasma pTau217 concentration
-Plasma pTau217 / beta-amyloid 1-42 ration
-SF-36v2 Standard Version
-Fatigue VAS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants will consume three pieces per day of the test food (containing potato ceramide extract) with water or lukewarm water.
Interventions/Control_2
Participants will consume three pieces per day of the placebo (without potato ceramide extract) with water or lukewarm water.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 55 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
-Aged 55 to under 80 years at consent
-Japanese men and women
-Self-awareness of memory loss or have been pointed out to have memory loss
-Mini-Mental Sate Examination (MMSE) total score of 24 or higher at SCR2
-Able to enter electronic diaries via smartphone or PC
-Voluntarily consented in writing after receiving sufficient explanation and understanding of the study's purpose and content
Key exclusion criteria
-Suspected cognitive impairment due to metabolic disease, head injury, normal pressure hydrocephalus, epilepsy, encephalitis, or meningitis
-Comorbid or suspected neurodegenerative diseases presenting with dementia-like symptoms (e.g., Parkinson's disease, dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, progressive supranuclear palsy, corticobasal degeneration, multiple system atrophy, multiple sclerosis)
-Current or past unstable or severe psychiatric disorders, including sleep apnea (on CPAP), major depression, bipolar disorder, schizophrenia, alcohol or substance dependence
-History of cerebrovascular disease (e.g., past TIA, post-treatment epilepsy)
-Scheduled hospitalization (including for tests) at consent
-Current or past use of medications affecting cognition (e.g., antidepressants)
-Current or past serious diseases that may affect the study (e.g., severe heart or liver disease)
-Use of hearing aids due to age-related hearing loss
-Eye disorders affecting eye-tracking cognitive assessments
-History of gastrointestinal surgery (except appendicitis)
-Regular intake (3 or more times a week) of products affecting cognition (e.g., certain supplements or foods), unless discontinued after consent
-Regular use (3 or more times a week) of devices or apps affecting cognition (e.g., brain training), unless discontinued after consent
-Current or past food or drug allergies
-taking alcohol more than 40 g/day
-with excessive daily smoking: 20 or more cigarettes a day
-Shift workers with night shifts
-Plans to significantly change lifestyle (diet, sleep, exercise) during the study
-Plans for overseas travel during the study
-Blood donation or sampling exceeding 200ml in the past month or 400ml in the past 3 months, or planned during the study
-Participation in other clinical studies within 1 month before consent, currently, or planned during the study
-Deemed unsuitable for participation by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Masutomi |
Organization
Calbee, Inc.
Division name
Functional Research Section, Research Department, Research & Development Division
Zip code
321-3231
Address
Utsunomiya, Tochigi, 321-3231, Japan
TEL
070-3872-7681
h_masutomi@calbee.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Calbee, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suda Clinic institutional review board
Address
2-8-14, Takadanobaba, Shinjyuku, Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2027 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 14 | Day |
Last modified on
| 2026 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072040
